Inspire Medical Systems, Inc.

Inspire Medical Systems, Inc. is a medical technology company that develops and sells minimally invasive solutions for patients with obstructive sleep apnea ("OSA"). The company's main product is the Inspire system, a neurostimulation technology approved by the FDA, the European Union ("EU") Medical Devices Regulation, and Japan's Pharmaceuticals and Medical Devices Agency. This system is designed to treat patients with moderate to severe OSA. The Inspire system is a closed-loop solution that continuously monitors a patient's breathing and delivers mild stimulation to the hypoglossal nerve to keep the airway open. Clinical data, including a publication in the New England Journal of Medicine and over 385 peer-reviewed publications, supports the safety and effectiveness of Inspire therapy. The FDA granted premarket approval ("PMA") for Inspire therapy in 2014. It has been commercially available in certain European markets since 2011, and Japan's Ministry of Health, Labour and Welfare ("MLHW") approved it in 2018. Inspire therapy is indicated for patients with moderate to severe OSA who do not have significant central sleep apnea and do not have a complete concentric collapse of the airway at the soft palate level. More than 125,000 patients have been treated with Inspire therapy in the United States ("U.S."), Europe, and Asia. OSA is a chronic disease where breathing is interrupted during sleep due to a partially or completely blocked airway. Moderate OSA is defined by an apnea-hypopnea index ("AHI") of 15 to 30 events per hour, while severe OSA involves an AHI of 30 or more events per hour.